Your Dog as a Medical Device?

A quick Google search of “dog trained to identify medical conditions” indicates that, around the world, dogs are already working with people to help sniff out certain medical conditions. For example, in the United Kingdom an organization called “Medical Detection Dogs” works “to train specialist dogs to detect the odour of human disease.” Those dogs have been trained to identify the odor associated with low blood sugar in diabetics, as well as to assist in conditions such as Addison’s disease, pain seizures, and narcolepsy.

On December 13, 2012, BMJ published an article titled “Using a dog’s superior olfactory sensitivity to identify Clostridium difficile in stools and patients: proof of principle study.” This study took place in two hospitals in the Netherlands. A two-year old beagle, Cliff, was trained to identify the smell of C difficile and tested on 300 patients (30 with C diff infection and 270 controls). The dog, trained to sit or lie down when C diff was detected, was guided along the wards by its trainer, who was blinded to the participants’ infection status. Cliff was able to correctly identify 25 of the 30 cases (sensitivity 83%,) and 265 of the 270 controls (specificity 98%). This compares favorably with the diagnostic performance of some diagnostic kits.

Cliff’s success at detecting a highly transmissible and dangerous infection, and use of dogs to assist in caring for individuals with chronic conditions, potentially offers great promise for the management of many diseases. The question arises, however, whether FDA would appreciate the potential of man’s best friend, and let dogs be dogs, or if it could, and would, stretch its authority to actually attempt to regulate dogs as medical devices when they are “intended” for such medical purposes.

The question is not necessarily as far-fetched as it may seem at first glance. Keep in mind that FDA currently regulates maggots and leeches as medical devices. If they fit under the statutory definition of a device, why couldn’t a dog that is trained and promoted for its ability to sniff out C diff? While this might seem like a shaggy dog joke, it is both a potentially vexing FDA issue, and a great law school exam question.

Let’s hope we never have to engage with FDA on this issue and, as they say, let sleeping dogs lie.